Who is sponsoring NCT05348811?

NCT05348811 is sponsored by Zhongda Hospital.

What drugs are being tested in NCT05348811?

Interventions in NCT05348811: HAIC combined with donafenib and sintilimab.

What condition does NCT05348811 study?

NCT05348811 studies Cholangiocarcinoma.

Is NCT05348811 still recruiting?

NCT05348811 is currently completed. Last updated 6 January 2026.

Last reviewed 2026-01-06 · How we verify

NCT05348811

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

HAIC Combined With Donafenib and Sintilimab for Unresectable ICC

Completed Phase 2 Last updated 6 January 2026

What this trial tests

Phase 2 trial testing HAIC combined with donafenib and sintilimab in Cholangiocarcinoma in 25 participants. Completed in 1 October 2025.

Timeline

13 June 2022

Primary endpoint
1 October 2025

1 October 2025

Quick facts

Lead sponsor	Zhongda Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	13 June 2022
Primary completion	1 October 2025
Estimated completion	1 October 2025
Sites	1 location across China

Drugs / interventions tested

HAIC combined with donafenib and sintilimab — full drug profile →

Conditions studied

Cholangiocarcinoma — all drugs for Cholangiocarcinoma →

Sponsor

Zhongda Hospital

Who can join

Adults 18 to 75, any sex, with Cholangiocarcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate the safety and tolerability of HAIC combined with donafenib and sintilimab in first-line treatment of unresectable ICC.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Deuterium in drug discovery: progress, opportunities and challenges.
Di Martino RMC, Maxwell BD, Pirali T. · · 2023 · cited 228× · PMID 37277503 · DOI 10.1038/s41573-023-00703-8
Current and Emerging Therapeutic Targets for the Treatment of Cholangiocarcinoma: An Updated Review.
Hadfield MJ, DeCarli K, Bash K, Sun G, et al · · 2023 · cited 12× · PMID 38203714 · DOI 10.3390/ijms25010543
Current Status of Targeted Therapy for Biliary Tract Cancer in the Era of Precision Medicine.
Mie T, Sasaki T, Okamoto T, Furukawa T, et al · · 2024 · cited 5× · PMID 38473240 · DOI 10.3390/cancers16050879
Update on Locoregional Therapies for Cholangiocellular Carcinoma.
Morawitz J, Bruckmann NM, Jannusch K, Kirchner J, et al · · 2023 · cited 5× · PMID 37190295 · DOI 10.3390/cancers15082368
Potential Immunotherapy Targets for Liver-Directed Therapies, and the Current Scope of Immunotherapeutics for Liver-Related Malignancies.
Charles J, Vrionis A, Mansur A, Mathias T, et al · · 2023 · cited 4× · PMID 37174089 · DOI 10.3390/cancers15092624
Conversion treatment for advanced intrahepatic cholangiocarcinoma: Opportunities and challenges.
Liu JJ, Zhou M, Yuan T, Huang ZY, et al · · 2025 · cited 3× · PMID 40309227 · DOI 10.3748/wjg.v31.i15.104901

Verify or expand the search:

Other recruiting trials for Cholangiocarcinoma

Currently open trials in the same condition.

NCT07486713 — Olutasidenib DDI Study in Patients With IDH1 Mutation Positive Malignancies · Phase 4 · recruiting
NCT07291947 — PULSAR Combined With Immunotherapy and Chemotherapy · Phase 1, PHASE2 · recruiting
NCT07359586 — Laryngopharyngeal Injury After Endotracheal Intubation Under General Anesthesia · recruiting
NCT07263217 — Mechanistic Study on the Protective and Regenerative Effects of Spirulina in Hepatectomy-Related Liver Injury · NA · recruiting
NCT07155525 — Tissue Adhesive Glue Modified Cyanoacrylate (Glubran® 2) in Soft Pancreas · Phase 3 · recruiting

Other Zhongda Hospital trials

Trials by the same sponsor.

NCT07516704 — Safety and Efficacy of Docetaxel, Darolutamide, and Homoharringtonine Combined With Androgen Deprivation Therapy in Neoa · EARLY_PHASE1 · not yet recruiting
NCT07504731 — Trunk Inclination, Positive End-expiratory Pressure, and Lung Recruitability · recruiting
NCT07351669 — A Multicenter Prospective Study on the Performance of Spectral CT for Evaluating Treatment Response After TACE in Hepato · recruiting
NCT07311915 — Propranolol Combined With Novel Endocrine Therapy and Androgen Deprivation Therapy (ADT) for Neoadjuvant Treatment in Hi · NA · not yet recruiting
NCT07585877 — Effect of Branched-Chain Amino Acid Supplementation on Myopia Progression · NA · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05348811 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Zhongda Hospital
Last refreshed: 6 January 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05348811.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing